Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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It was reported by the clinical support specialist (css) that there was a ruptured intra-aortic balloon (iab).There is no information regarding the situation.It was stated by the biomed that there was no patient on the pump at the time of the call.
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Manufacturer Narrative
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(b)(4).The product was not returned for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported by the clinical support specialist (css) that there was a ruptured intra-aortic balloon (iab).There is no information regarding the situation.It was stated by the biomed that there was no patient on the pump at the time of the call.
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Search Alerts/Recalls
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